Technical Field
The disclosed technology relates generally to medical devices, and more particularly, some embodiments relate to neuromodulation and implantable medical devices that provide proximal and distal stability to a stimulator lead, pain pump, and/or other similar medical devices that may be placed in the epidural space.
Description of the Related Art
Spinal stimulation has been in practice as a means of pain control for patients after the gate theory was proposed in 1965 by Melzack and Wall. Spinal cord stimulation through implantable means was performed by Shealy et al. for the treatment of chronic pain where the first spinal cord stimulator was placed within the dorsal column for treatment of chronic pain shortly after the discovery of Melzack and Wall.
Traditionally, a spinal cord stimulation lead typically comes in two types of leads. The first, is a wire-like lead with leads that are placed at the end of the wire, i.e., the distal end. A second type of spinal cord stimulator lead is a surgical lead or a paddle lead that typically has a wider area of stimulation. This second type of spinal cord stimulator lead is generally inserted under surgical technique and may require partial laminotomy to be performed (also known as a paddle lead), and also has its stimulation portion or site at the distal end of the wire or paddle where the first part of the leads would be considered the proximal end.
In providing analgesic relief to patients with pain, spinal cord stimulator leads may provide electrical stimulation using an electric pulse generator that may be connected to conducting wires that subsequently connect or reach the distal portion of the wire where either the leads of the wire or the leads of the paddle are located. Thus, when stimulated, the leads adjacent to the spinal cord dura would provide stimulation that will help alleviate pain. With either percutaneous or surgically implanted stimulator leads, the current practice allows control from only the proximal end of the stimulator leads. This makes it very difficult for the practitioner to accurately position the stimulator lead in the correct location in the epidural space in order to provide appropriate pain relief. Insertion of the stimulator lead may traverse many levels of the spine and the only control to date is from the proximal end (end closest to practitioner from where it is inserted in the body). In standard practice today, conventional stimulator leads have no control mechanism where the practitioner may control the distal end of the lead (the portion furthest away from the point of entry of the body as well as the practitioner). Having only one entry point and one point of control makes not only navigation difficult for spinal cord stimulation, but also leads to other issues such as lead migration and lead retrieval issues if the leads break while inside the body.